Evaluation of a Structured Nutrition Educational Program Among Patients With Type 2 Diabetes
Evaluation of a Structured Nutrition Education Program for Patients With Type 2 Diabetes Who Have Not Achieved Glycemic Goals Under Oral Anti-diabetic Medications or in Combination With Basal Insulin in Vietnam
The purpose of this study is to find out if learning about healthy eating can help people with diabetes control their blood sugar better.
This study is for men and women between 16 and 70 years old who currently use only oral-diabetic medications or in combination with basal insulin but their glycemia have not been in the target range.
The investigators want to answer the following questions:
Can nutrition education help lower HbA1c (a blood test that shows average blood sugar over the past 3 months)? Can it improve nutrition related knowledge, attitude and behaviors among patients with type 2 diabetes? Will it help reduce fasting blood sugar, lipid levels, body weight, and the number of times low blood sugar (hypoglycemia) happens?
Participants will be divided into two groups:
One group will receive a nutrition booklet. The other group will receive the same booklet and join four monthly lessons with a researcher.
The four lessons will talk about:
Goals for managing diabetes Main nutrients in food and their effects on glycemia How to plan meals How to eat in a way that supports better blood sugar control
연구 개요
상세 설명
This study will involve 253 people with diabetes who currently uses only oral anti-diabetic medications or in combination with basal insulin without their glycemia within the target range.
The study will take place at Cho Ray Hospital in Ho Chi Minh City, Vietnam, and will run from 2026 to 2027. People will be invited to join at the Endocrinology Consultation Unit. If they agree, their phone number will be collected and the research team will call them later to explain more about the study. If they are still interested, a meeting with the researcher will be planned on the day of their next consultation. During this meeting, the patients will be screened for their eligibility.
On the screening day, the patients will have their blood tests to check their sugar, HbA1c, cholesterol, and kidney function as part of their routine visit and have a usual consultation with their doctor. If the patients meet all the criteria and agree to take part in, the patients will sign the consent form and take short tests on nutrition related knowledge, attitude, and behavior questionnaire designed and evaluated by the researcher.
After that, the patients will be randomly assigned to one of two groups. One group will get a nutrition booklet only. The other group will receive the booklet plus attend four monthly sessions with a researcher to learn about healthy eating for diabetes.
During the 6-month study period, all participants will have blood tests every 3 months to check HbA1c, fasting sugar, and lipid; the participants will be asked monthly about any low blood sugar episodes; their weight and waist size will be measured every 3 months, and their height will be measured at the start of the study. The participants will be interviewed with the nutrition related knowledge-attitude-behavior questionnaire again after 6 months.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Na Ly Dau, MD
- 전화번호: +49379942392
- 이메일: Ly.Dau@lrz.uni-muenchen.de
연구 장소
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Ho Chi Minh City, 베트남, 700000
- Cho Ray Hospital
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연락하다:
- Na Ly Dau, MD
- 전화번호: +49379942392
- 이메일: Ly.Dau@lrz.uni-muenchen.de
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수석 연구원:
- Na Ly Dau, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- People between 16 and 70 years old.
- People who come to Cho Ray Hospital for diabetes care and plan to keep getting care there for at least six months.
- People who have diabetes and have been prescribed diabetes medicine.
- People who were recently diagnosed with diabetes, based on the latest guidelines from the American Diabetes Association.
- People whose blood sugar (HbA1c) level is higher than 7.5 %.
- People who are currently using only oral anti-diabetic medications or in combination with basal insulin
Exclusion Criteria:
- People who are seriously ill and need to stay in the hospital, such as those with infections, pneumonia, heart attacks, strokes, or infected diabetic foot.
- People who have cancer, serious mental health problems, or problems with drug use.
- People who do not want to take part or cannot follow the study plan.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: Standard group
The participants of this group will be given a nutrition booklet and follow the standard of care, which means the participants routinely have about 5 to 10-minute consultations with their doctors.
During this time, the participants tell their doctors about how they feel physically, their doctors then examine the patients, educate them if necessary, and prescribe the tests and medications.
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실험적: Nutrition Intervention group
Participants in the intervention group will attend a structured nutrition education program consisting of four monthly sessions, each lasting approximately 40 to 60 minutes.
These sessions will be conducted in small groups by the researcher.
Each session includes: A 20-minute presentation delivered by the researcher using visual aids, such as slides and educational images, a 15-minute Q and A section, and 20 minutes of working on group assignments.
Session Topics: Treatment Goals in Diabetes Care: Overview of blood glucose targets and the importance of achieving glycemic control.
Key Nutritional Components of Food: Roles of carbohydrates, proteins, fats, fiber, and their impact on blood glucose.
Principles of Meal Planning: Adjusting energy intake based on physical activity levels and BMI.
Understanding the Food Exchange System: Introduction to food exchange lists; selecting the appropriate number of food exchanges.
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Experimental: Nutrition intervention group Arm Description: Participants in the intervention group will attend a structured nutrition education program consisting of four monthly sessions, each lasting approximately 40 to 60 minutes.
These sessions will be conducted in small groups by the researcher.
Each session includes: A 20-minute presentation delivered by the researcher using visual aids, such as slides and educational images, a 15-minute Q and A section, and 20 minutes of working on group assignments.
Session Topics: Treatment Goals in Diabetes Care: Overview of blood glucose targets and the importance of achieving glycemic control.
Key Nutritional Components of Food: Roles of carbohydrates, proteins, fats, fiber, and their impact on blood glucose.
Principles of Meal Planning: Adjusting energy intake based on physical activity levels and BMI.
Understanding the Food Exchange System: Introduction to food exchange lists; selecting the appropriate number of food exchanges.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Hba1c (%) from baseline to 6 months, comparing intervention vs control
기간: 6 months
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the change in Hba1c (%) from the baseline to 6 months, comparing intervention vs standard group
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in HbA1c (%) from baseline to 3 months, comparing intervention vs control
기간: 3 months
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Change in HbA1c (%) from baseline to 3 months, comparing intervention vs standard group
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3 months
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Change in BMI from baseline to 3 months and 6 months, comparing the intervention vs control
기간: 3 months and 6 months
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Change in BMI from baseline to 3 months and 6 months, comparing the intervention vs standard group
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3 months and 6 months
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Differences of total daily insulin dose after 3 months and after 6 months, comparing the intervention vs control
기간: 3 months and 6 months
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Differences of total daily insulin dose after 3 months and after 6 months, comparing the intervention vs standard groups
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3 months and 6 months
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Difference of number of distinct anti-diabetic medication classes used per day after 3 months, and after 6 months, comparing the intervention vs control
기간: 3 months, and 6 months
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Difference of number of distinct anti-diabetic medication classes used per day after 3 months, and after 6 months, comparing the intervention vs standard group
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3 months, and 6 months
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Differences in daily doses of each oral anti-diabetic medication and dyslipidemia medication after 3 months, and after 6 months, comparing the intervention vs control
기간: 3 months, and 6 months
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Differences in daily doses of each oral anti-diabetic medication and dyslipidemia medication after 3 months, and after 6 months, comparing the intervention vs standard group
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3 months, and 6 months
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Changes in nutrition-related knowledge, attitude and behavior score from baseline to 6 months, comparing the intervention vs control
기간: 6 months
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Changes in nutrition-related knowledge, attitude and behavior score from baseline to 6 months, comparing the intervention vs standard group
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6 months
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Difference in possible self-reported hypoglycemia episodes recorded in the previous month from baseline to 3 months, and to 6 months, comparing the intervention vs control
기간: 3 months and 6 months
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Difference in possible self-reported hypoglycemia episodes recorded in the previous month from baseline to 3 months, and to 6 months, comparing the intervention vs standard group
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3 months and 6 months
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Change in waist circumference from baseline to 3 months and 6 months, comparing the intervention vs control
기간: 3 months and 6 months
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Change in waist circumference from baseline to 3 months and 6 months, comparing the intervention vs standard group
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3 months and 6 months
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Change in fasting blood glucose from baseline to 3 months and 6 months, comparing the intervention vs control
기간: 3 months and 6 months
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Change in fasting blood glucose from baseline to 3 months and 6 months, comparing the intervention vs standard group
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3 months and 6 months
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Change in LDL cholesterol from baseline to 3 months and 6 months, comparing the intervention vs control
기간: 3 months and 6 months
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Change in LDL cholesterol from baseline to 3 months and 6 months, comparing the intervention vs standard group
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3 months and 6 months
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Change in Total triglyceride from baseline to 3 months and 6 months, comparing the intervention vs control
기간: 3 months and 6 months
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Change in Total triglyceride from baseline to 3 months and 6 months, comparing the intervention vs standard group
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3 months and 6 months
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Change in total cholesterol from baseline to 3 months and 6 months, comparing the intervention vs control
기간: 3 months and 6 months
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Change in total cholesterol from baseline to 3 months and 6 months, comparing the intervention vs standard group
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3 months and 6 months
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Change in HDL cholesterol from baseline to 3 months and 6 months, comparing the intervention vs control
기간: 3 months and 6 months
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Change in HDL cholesterol from baseline to 3 months and 6 months, comparing the intervention vs standard group
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3 months and 6 months
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Differences of daily number of insulin injections after 3 months and after 6 months, comparing the intervention vs control
기간: 3 months and 6 months
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Differences of daily number of insulin injections after 3 months and after 6 months, comparing the intervention vs standard groups
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3 months and 6 months
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Differences of total daily slow-acting insulin dose after 3 months and after 6 months, comparing the intervention vs control
기간: 3 months and 6 months
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Differences of total daily slow-acting insulin dose after 3 months and after 6 months, comparing the intervention vs standard groups
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3 months and 6 months
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Differences of total daily fast-acting insulin dose after 3 months and after 6 months, comparing the intervention vs control
기간: 3 months and 6 months
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Differences of total daily fast-acting insulin dose after 3 months and after 6 months, comparing the intervention vs standard groups
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3 months and 6 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Difference in cost-effectiveness ratios (monthly per-patient cost for diabetic care per unit of improvement in glycemic control) after six months, comparing the intervention vs control.
기간: 6 months
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Difference in cost-effectiveness ratios (monthly per-patient cost for diabetic care per unit of improvement in glycemic control) after six months, comparing the intervention vs standard group.
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6 months
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Na Ly Dau, MD, Cho Ray Hospital
간행물 및 유용한 링크
일반 간행물
- Davies MJ, Aroda VR, Collins BS, Gabbay RA, Green J, Maruthur NM, Rosas SE, Del Prato S, Mathieu C, Mingrone G, Rossing P, Tankova T, Tsapas A, Buse JB. Management of Hyperglycemia in Type 2 Diabetes, 2022. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2022 Nov 1;45(11):2753-2786. doi: 10.2337/dci22-0034.
- Franz MJ, MacLeod J, Evert A, Brown C, Gradwell E, Handu D, Reppert A, Robinson M. Academy of Nutrition and Dietetics Nutrition Practice Guideline for Type 1 and Type 2 Diabetes in Adults: Systematic Review of Evidence for Medical Nutrition Therapy Effectiveness and Recommendations for Integration into the Nutrition Care Process. J Acad Nutr Diet. 2017 Oct;117(10):1659-1679. doi: 10.1016/j.jand.2017.03.022. Epub 2017 May 19. No abstract available.
- Subhan FB, Fernando DN, Thorlakson J, Chan CB. Dietary Interventions for Type 2 Diabetes in South Asian Populations-A Systematic Review. Curr Nutr Rep. 2023 Mar;12(1):39-55. doi: 10.1007/s13668-022-00446-9. Epub 2022 Nov 29.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- ChoRay_OMIN_2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
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